Comparison of Isometric and Isotonic Strengthening Exercises in Chronic Neck Pain Patients.

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05865951
Collaborator
(none)
22
1
2
5
4.4

Study Details

Study Description

Brief Summary

Study will be a Randomized clinical trial to check the effects of isometric and isotonic strength training exercises on patients with chronic neck pain. The data will be collected in a hospital setting where patients of chronic mechanical neck pain will be screened out for the fulfillment of eligibility criteria of this study. After being eligible for this study their baseline outcome measures will be measured using Numeric pain rating scale, neck disability index, goniometer, dynamometer and short form 36 survey. Then they will be divided into two groups namely group A receiving isometric exercises with conventional treatment and group B receiving isotonic exercises with conventional treatment. Here conventional treatment includes thermotherapy, manual mobilisation of cervical and thoracic and trigger point therapy which will be a common treatment for both groups. The outcome measures will be measured later at 4th,8th and 12th week.

Condition or Disease Intervention/Treatment Phase
  • Other: Isometric Exercises
  • Other: Isotonic Exercises
N/A

Detailed Description

Chronic neck pain is a burden to health globally and is the major reason behind years of disability. This is due to the higher prevalence, persistence and recurrence.It is a frequent reason for visit to physical therapist or a physician. It is the major health concern for society these days with highest recurrence rate combined with its chronicity. The overall worldwide prevalence for it is 16.7% to 75.1%. There is scarce knowledge of use of isotonic neck muscles strengthening in clinical trials. Moreover the literature has not satisfied the long term effects of isometric and isotonic strength training exercises of cervical muscles on improving the health related quality of life and restoring the normal function of cervical spine.

The findings of current study will help to establish long term effects of isometric and isotonic strengthening exercises on pain, strength, function and quality of life in chronic mechanical neck pain patients.

Neck strength training exercises have shown to reduce neck muscle injuries in sports.Neck strength training has also proved beneficial in reducing neck pain as part of training.

The static muscle contractions of neck muscles of patient being seated with the resistance of palm of physiotherapist being standing will be performed in six cervical movements i.e. flexion, extension, right lateralflexion, left lateral flexion, right rotation, left rotation.

The dynamic muscle contractions of neck muscles will be performed using thera-band for resistance tied on the wall for all six movements of cervical spine.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Long-term Comparative Effects of Isometric and Isotonic Global Neck Muscles Strengthening Exercise Program on Pain, Range of Motion, Strength, Function, and Quality of Life in Patients With Chronic Mechanical Neck Pain.
Actual Study Start Date :
Apr 15, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: chronic neck pain and isometric exercises group:

Group A performed exercises for 12 weeks. Participants performed isometric exercises along with conventional physical therapy treatment ( thermotherapy, manual mobilisation of cervical spine and trigger point therapy). All exercises were performed for 3 sessions per week for a period of 12 weeks.

Other: Isometric Exercises
Isometric (same length) strengthening exercises of the neck muscles will be performed.

Active Comparator: chronic neck pain and isotonic group

Group B performed exercises for 12 weeks. Participants performed isotonic exercises along with conventional physical therapy treatment ( thermotherapy, manual mobilisation of cervical spine and trigger point therapy). All exercises were performed for 3 sessions per week for a period of 12 weeks.

Other: Isotonic Exercises
Isotonic strengthening exercises for the neck muscles will be performed.

Outcome Measures

Primary Outcome Measures

  1. Numeric Pain Rating Scale (NPRS): [up to 12 weeks]

    It is a unidimensional outcome measure that is used for measuring intensity of chronic pain. It is a verbally administered scale rating from 0 to 10 where 10 quantifies worse pain intensity and 5 as a moderate intensity. The simplicity in pain scoring makes it a reliable scale with reliability 0.96 in literate and 0.95 in illiterate patients whereas validity ranges from 0.86 to 0.95.

  2. Universal GONIOMETER for Range of Motion [up to 12 weeks]

    It is the device used for measuring range of motion of joints. One of the type of goniometer to be used in this study is universal goniometer with two arms, one arm is maintained at neutral position whereby the other arm moves with the moving part of body. The inter-observer reliability remains at 0.99 whereas validity being 0.97

  3. Hand-Held DYNAMOMETER for muscle strength measurement [up to 12 weeks]

    Dynamometer is a hand-held device used to measure thestrength of muscles. It is to be placed as a resistance in the movement to quantify the muscle strength into force unit. It has reliability from 0.94 to 0.97.

  4. NECK DISABILITY INDEX (NDI): [up to 12 weeks]

    It is a function specific questionnaire designed to measure thelevel of disability and restriction in activities of daily living. It comprises of 10 questions about daily living while the score is converted to percentage where 0% indicates no limitation in function while 50-100% indicates complete activity limitation. It has moderate test re-test reliability where ICC varies between 0.50 and 0.98, while it constructs a good validity.

Secondary Outcome Measures

  1. 36-Item Short Form Survey (SF-36) for quality of life [up to 12 weeks]

    This survey quantifies the quality of life. It comprises of 36questions related to health, physical activity and psychology. It has shown to be reliable and a valid questionnaire.Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high quality of life.SF-36 scores range from 0 (worst) to 100 (best).

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • No discrimination against gender

  • Age group 25-55 years

  • Complain of chronic mechanical neck pain from more than 3 months

Exclusion Criteria:
  • • Spinal cord injury

  • Malignancy

  • Cervical fracture

  • Any bony or soft tissue systemic disease

  • Ankylosis spondylitis

  • Craniovertebral disorders

  • Any cervical deformity

Contacts and Locations

Locations

Site City State Country Postal Code
1 Noor Fatima Hospital Dinga Punjab Pakistan 54700

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Misha Butt, MS*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05865951
Other Study ID Numbers:
  • REC/RCR & AHS/23/0117
First Posted:
May 19, 2023
Last Update Posted:
May 19, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2023